According to a media release from Cougar Biotechnology, a second Phase III clinical trial of abiraterone acetate started today — for men with castration-resistant prostate cancer (CRPC) who have not received chemotherapy.
According to the media release, this trial (COU-AA-302) is a randomized, double-blind, placebo-controlled trial of abiraterone acetate plus prednisone vs. placebo + prednisone in patients with metastatic CRPC who have not yet received treatment with chemotherapy. The trial is expected to enroll approximately 1,000 patients who will be randomized (1:1) to receive either active drug + prednisone or placebo + prednisone. The trial will be conducted at approximately 150 sites in North America, Europe and Australia. The co-primary endpoints of the trial are progression-free survival and overall survival.
Full eligibility criteria for this trial is available on ClinicalTrials.gov. We expect that the complete list of clinical trial sites will be available on that link shortly.
Filed under: Drugs in development Tagged: | abiraterone acetate, CRPC, Phase III
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Can you please advise me who maybe handling the trials in Australia?
Peter
Dear Peter:
At present the only Australian trial site listed on the ClinicalTrials.gov trial protocol is Haematology & Oncology Clinics of Australasia in South Brisbane, Queensland 4101, Australia. You can contact the trial coordinator, Kate O’Neill, by calling 61-2-3737-4750 or by sending her an e-mail. (The supervising physician at that site is Paul Mainwaring, MD.) However, if there is one site up and running, I would expect more within the very near future.
Abiraterone seems to be the only lifeline open to me, but after scanning the internet I can find no reference to any trials in South Africa. Is there any likelihood of future trials in my country?
Dear Mr. Graham:
Previous trials of abiraterone have not included trials sites in South Africa. Now that Johnson & Johnson has taken over Cougar Biotechnology, it is possible that they will open trial sites in South Africa, but I do not think it is going to happen in a hurry.
What you might want to look up (on the ClinicalTrials.gov web site) is the trial of AstraZeneca’s endothelin antagonist, which is being tested in a randomized Phase III trial that does include South African sites.
Are there any abiraterone trials accepting men with atrial fibrillation? I am eligible except that I have AFib (under control for many years). I would appreciate any information you could provide.
Dear Mr Becker:
Cougar Biotechnology provides a phone number (310-943-8040) that you can call to get additional information about the open abiraterone trial for patients with hormone refractory prostate cancer who have not had chemotherapy.
Phone numbers are also available for the clinical trial recruitment sites around the world. Your best bet is to call the Cougar Biotechnology phone number or the clinical trial recruitment sites near to where you live.
The “New” Prostate Cancer InfoLink is unable to provide this type of detailed information for every ongoing clinical trial in prostate cancer.
My dad has been diagnosed with locally advanced prostate cancer recently, and we would like to try this drug as well. I would be very appreciative if we could be considered in clinical trial. Our doctor also would like to try but we are in Bangkok, Thailand?! Is it possible to help my dad please?
Dear Teraphan:
Abiraterone acetate is likely to be approved in the USA for the treatment of very advanced forms of prostate cancer early in 2011. Unfortunately we have no way to be able to influence who is enrolled in clinical trials. Patients have to be able to go to specific, approved trial centers. There are two small trials testing abiraterone in men like your father — but both of those trials are being carried out at centers in the USA. We do not believe that abiraterone is available for prostate cancer patients in Thailand at the present time.
I live in the UK and would like to order abiraterone from the USA. How do I do this?
Dear Malcolm:
Unfortunately, as far as I am aware, there is no way to do this. It is not legal in either the UK or the USA. However, if you have already been treated with docetaxel-based chemotherapy, you may be eligible to participate soon (in the UK) in the continuing compassionate use trial of abiraterone acetate.
As yet there are no trial sites open in the UK, but if you contact the Royal Marsden Hospital in Sutton, they may be able to tell you whether they expect to be enrolling patients in this trial.